A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Primary completion date changed from estimate of Jun 1, 2027 to Oct 1, 2026
    • Study completion moved earlier from Dec 1, 2029 to Mar 30, 2029
    • Eligibility criteria expanded, about 19 words
    • Site details revised at 2 of 68 sites
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 130
    • Study sites: 70 to 68
    v35
  3. Re-verified, no change to tracked fieldsv34
  4. Site details revised at 1 of 70 sitesv33
  5. Site details revised at 2 of 70 sitesv32
Show 30 earlier versionsHide 30 earlier versions
  1. Study sites revised (70)v31
  2. Site details revised at 2 of 70 sitesv30
  3. Site details revised at 2 of 70 sitesv29
  4. Site details revised at 1 of 70 sitesv28
  5. Site details revised at 2 of 70 sitesv27
  6. Site details revised at 1 of 70 sitesv26
  7. Study sites revised (70)v25
  8. Site details revised at 2 of 70 sitesv24
  9. Study sites: 71 to 70v23
  10. Site details revised at 1 of 71 sitesv22
  11. Site details revised at 3 of 71 sitesv21
  12. Study sites: 70 to 71v20
  13. Site details revised at 2 of 70 sitesv19
  14. Site details revised at 1 of 70 sitesv18
  15. Site details revised at 1 of 70 sitesv17
  16. Site details revised at 1 of 70 sitesv16
  17. Study sites revised (70)v15
  18. Site details revised at 3 of 70 sitesv14
  19. Site details revised at 7 of 70 sitesv13
  20. Site details revised at 4 of 70 sitesv12
  21. Site details revised at 2 of 70 sitesv11
  22. Site details revised at 5 of 70 sitesv10
  23. Study sites revised (70)v9
  24. Site details revised at 1 of 70 sitesv8
  25. Study sites: 69 to 70v7
  26. Study sites: 68 to 69
    • Start date changed from estimate of Oct 17, 2024 to Oct 11, 2024
    v6
  27. Study sites: 69 to 68
    • Start date: Sep 29, 2024 to Oct 17, 2024
    v5
  28. Site details revised at 1 of 69 sitesv4
  29. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 62 to 69
    • Start date: Sep 11, 2024 to Sep 29, 2024
    v3
  30. Start date: Jul 8, 2024 to Sep 11, 2024
    • Study sites: 0 to 62
    • Primary completion date: Mar 5, 2027 to Jun 1, 2027
    • Study completion date: Sep 5, 2028 to Dec 1, 2029
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Incyte
94 trials monitored
See 8 trials at risk
This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
Trial Details
NCT Number NCT06388564
Lead Sponsor Incyte Corporation
Conditions
(from sponsor)		 Chronic Graft-versus-host-disease
Related terms Bronchiolitis Obliterans Syndrome
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov